Chronic Pain, Multiple Sclerosis, Neurological Disorder
Conditions
Brief summary
Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.
Interventions
DEVICEHTC Vive Virtual Reality (VR) system
VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 18-79 years of age * Has been diagnosed by a clinician as having MS * Able to commit to the designated period of testing * Able to understand the informed consent process and provide consent to participate in the study * Capacity to complete study procedures as determined by screening personnel * A Brief Pain Inventory interference score of at least 3 or more. * SDMT Z-Score \> -3.0 * WRAT4 Standard Score \> or = 85
Exclusion criteria
* Visual, auditory, and motor deficits that would prevent full ability to understand study * Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment * Uncontrolled epilepsy * Current diagnosis of vertigo * Uncontrolled mood disorders * History of Psychosis or Schizophrenia * Expanded Disability Status Scale (EDSS) Score greater than 6.5 * Unable to tolerate or manipulate VR treatment procedures (as evidenced by VR capability assessment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score | Baseline (Week 1), Treatment End (Week 4) | PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score | Baseline (Week 1), Treatment End (Week 4) | Neuro-QOL - Fatigue - Short Form consists of 8 statements -- participants report on fatigue symptoms experienced in the past 7 days. Each statement is scored 1 (never) to 5 (always). The total score range is 8-40; the higher the score, the more severe the fatigue. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score | Baseline (Week 1), Study End (Week 5) | PROMIS - Sleep Related Impairment consists of 16 items. Participants report on sleep related impairment experienced in the past 7 days. Each statement is scored between 1 (not at all) and 5 (very much). The total score range is 16-80; the higher the score, the higher the level of sleep related impairment. |
| Change in PROMIS - Fatigue Score | Baseline (Week 1), Treatment End (Week 4) | PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain Participants with MS will only be able to receive eight treatment sessions in this study group and will complete their treatment over four weeks. Two treatments sessions must be completed each week (of the four weeks) and separated by at least one day.
Participants will attend a baseline visit with assessment and training procedures and receive their first treatment immediately after all baseline assessments. Participants will then complete the remaining seven treatment sessions over four weeks. At the final treatment session, participants will repeat assessments. One week following the final treatment session, participants will be asked to return to clinic to complete assessments once more to test cumulative benefits one week following treatment end.
HTC Vive Virtual Reality (VR) system: VR treatment will entail use of computer software designed to immerse participants and engage them in exercises. Software includes virtual painting, walking through vivid and calming settings, solving puzzles, among others. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Screen Failure | 1 |
Baseline characteristics
| Characteristic | People With Multiple Sclerosis (PwMS) and Chronic Pain |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 12.3757 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Time frame: Baseline (Week 1), Treatment End (Week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score | 0.42 score on a scale | Standard Deviation 1.11 |
Primary
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score
PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.
Time frame: Baseline (Week 1), Study End (Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a Score | 2 score on a scale | Standard Deviation 3.56 |
Secondary
Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score
Neuro-QOL - Fatigue - Short Form consists of 8 statements -- participants report on fatigue symptoms experienced in the past 7 days. Each statement is scored 1 (never) to 5 (always). The total score range is 8-40; the higher the score, the more severe the fatigue.
Time frame: Baseline (Week 1), Treatment End (Week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in Neuro-Quality of Life (Neuro-QOL) - Fatigue - Short Form Score | 5.5 score on a scale | Standard Deviation 10.4 |
Secondary
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score
PROMIS - Sleep Related Impairment consists of 16 items. Participants report on sleep related impairment experienced in the past 7 days. Each statement is scored between 1 (not at all) and 5 (very much). The total score range is 16-80; the higher the score, the higher the level of sleep related impairment.
Time frame: Baseline (Week 1), Study End (Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Score | 4 score on a scale | Standard Deviation 9.67 |
Secondary
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Time frame: Baseline (Week 1), Treatment End (Week 4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in PROMIS - Fatigue Score | 2.25 score on a scale | Standard Deviation 6.17 |
Secondary
Change in PROMIS - Fatigue Score
PROMIS-fatigue short form consists of 8 questions -- participants report on the intensity of fatigue experienced in the past 7 days. Each question is scored between 1 (had no fatigue) to 5 (always). The total score range is 8-40; the higher the score, the more intense the fatigue.
Time frame: Baseline (Week 1), Study End (Week 5)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| People With Multiple Sclerosis (PwMS) and Chronic Pain | Change in PROMIS - Fatigue Score | 3.88 score on a scale | Standard Deviation 10.54 |